BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

    MDR report key: 8592169 · Received May 8, 2019

    Report

    Report Number
    3005031160-2019-00025
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BACTERIN INTERNATIONAL, INC.
    Product Code
    MBP
    UDI-DI
    00849777003681
    PMA / PMN Number
    K130498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS WITH THIS EVENT. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025. THE COMPLAINANT RETURNED THREE ADDITIONAL DEVICES FROM THE SAME LOT NUMBER. UPON OPENING THE FOIL POUCH ON ONE DEVICE, IT WAS CONFIRMED THAT THE DBM PUTTY WAS AS DESCRIBED BY THE COMPLAINANT. THE DEVICE WAS LABELED AS CONTAINING 10.0CC OF DBM PUTTY, HOWEVER, ONLY CONTAINED 5.0CC OF DBM PUTTY.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383331 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BONE VOID FILLER MBP BACTERIN INTERNATIONAL, INC. 359100 B180228-DBM 00849777003681

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other